CONNECT: Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06004453

Collaborator

(none)

1,250

Enrollment

Locations

20.9

Anticipated Duration (Months)

17.9

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, non-randomized, non-interventional cohort study with prospective and retrospective collection of primary data on heart failure with reduced ejection fraction (HFrEF) patient treatment and care following a decompensation event in different types of Heart Failure Unit (HFU) or non-HFU centers across Germany.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Heart Failure medications

Detailed Description

This study aims to describe quality of care of HFrEF patients following a decompensation event in different center types (=settings) utilizing the quality indicators for the care and outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.

No strict visit schedule will be imposed on participants to avoid interference with routine clinical care. HFrEF patients will be treated according to the local routine in terms of medication, visit frequency and types of assessments performed and only these data will be collected as part of the study from patient files.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1250 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators

Actual Study Start Date :

Apr 5, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Cohort A Supra-regional HFU Centers and HFU Focus Hospitals	Other: Heart Failure medications There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.
Cohort B Non-HFU Hospitals	Other: Heart Failure medications There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.
Cohort C HFU Residential Cardiologists	Other: Heart Failure medications There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.
Cohort D Non-HFU Residential Cardiologists	Other: Heart Failure medications There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.
Cohort E General practitioners	Other: Heart Failure medications There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.

Outcome Measures

Primary Outcome Measures

Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint [6 months]
Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type. To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.

Secondary Outcome Measures

Proportion of sites with a dedicated multidisciplinary team to manage patients with HF [Baseline]
To describe the structural framework of the participating centers.
Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care. [Baseline]
To describe the structural framework of the participating centers.
(A) Proportion of patients with HF who have a documentation of their HF clinical type [Baseline]
HF clinical type: Heart failure with reduced ejection fraction (HFrEF), HF with a midrange ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF). To describe the patient assessment in different types of HFU and non-HFU centers.
(B) Proportion of patients with a documentation of their electrocardiogram findings [6 months]
To describe the patient assessment in different types of HFU and non-HFU centers.
(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation) [3 months]
To describe the patient assessment in different types of HFU and non-HFU centers.
(D) Proportion of patients who have their blood tests documented [3 months]
To describe the patient assessment in different types of HFU and non-HFU centers.
(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program [6 months]
To describe the patient assessment in different types of HFU and non-HFU centers.
(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge [4 weeks]
To describe the patient assessment in different types of HFU and non-HFU centers.
(G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022 [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
Percentage of days covered with all four treatment classes [6 months]
To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
(K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy [6 months]
To describe the therapy optimization in different types of HFU and non-HFU centers.
(L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator [6 months]
To describe the therapy optimization in different types of HFU and non-HFU centers.
Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool [6 months]
To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.
Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j [6 months]
To describe quality of treatment utilizing an all-or-none composite QI.
Number of HF hospitalizations, stratified by bed type [6 months]
Where a patient has multiple HF hospitalization stays, each hospitalization will be counted. To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Length of hospital stay [6 months]
Length of hospital stay will be considered as the time from admission date until discharge for each HF hospitalization. To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Number of HF hospitalizations per patient [6 months]
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Number of newly implanted devices [6 months]
implanted devices: implantable cardioverter defibrillator (ICD), Cardiac resynchronization therapy (CRT), combination of ICD and CRT (CRT-D). To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Number of valve interventions [6 months]
To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
Number of participants with medical history of selected comorbidities [Baseline]
To describe the HFrEF patient population with a recent decompensation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who provide written informed consent to participate in the study
Male or female patients ≥ 18 years of age
Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF treatment according to the summaries of product characteristics (SmPCs)
Decompensation event up to three months prior to inclusion

Exclusion Criteria:

Simultaneous or planned participation in an interventional research study
Participation in this study at another site e.g. in a HFU network
Patients incapable of understanding and signing the informed consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Winsen	Lower Saxony	Germany	21423
2	Novartis Investigative Site	Braunschschweig	Niedersachsen	Germany	38126
3	Novartis Investigative Site	Frankenthal	Pfalz	Germany	67227
4	Novartis Investigative Site	Kaiserslautern	Rhineland-Palatinate	Germany	67655
5	Novartis Investigative Site	Chemnitz	Saxony	Germany	09113
6	Novartis Investigative Site	Pirna	Saxony	Germany	01796
7	Novartis Investigative Site	Bad Neustadt		Germany	97616
8	Novartis Investigative Site	Bechhofen		Germany	66894
9	Novartis Investigative Site	Berlin		Germany	13053
10	Novartis Investigative Site	Berlin		Germany	D 10559
11	Novartis Investigative Site	Bexbach		Germany	66450
12	Novartis Investigative Site	Biedenkopf		Germany	35216
13	Novartis Investigative Site	Breuberg		Germany	64747
14	Novartis Investigative Site	Brilon		Germany	59929
15	Novartis Investigative Site	Brueel		Germany	19412
16	Novartis Investigative Site	Chemnitz		Germany	09116
17	Novartis Investigative Site	Coburg		Germany	96450
18	Novartis Investigative Site	Dessau-Rosslau		Germany	06847
19	Novartis Investigative Site	Dinkelsbuhl		Germany	91550
20	Novartis Investigative Site	Dresden		Germany	01277
21	Novartis Investigative Site	Dresden		Germany	01397
22	Novartis Investigative Site	Duesseldorf		Germany	40225
23	Novartis Investigative Site	Ehingen		Germany	89584
24	Novartis Investigative Site	Ehringshausen		Germany	35630
25	Novartis Investigative Site	Farchant		Germany	82490
26	Novartis Investigative Site	Frankfurt		Germany	60316
27	Novartis Investigative Site	Freiberg		Germany	09559
28	Novartis Investigative Site	Giengen		Germany	89537
29	Novartis Investigative Site	Goeppingen		Germany	73033
30	Novartis Investigative Site	Halle S		Germany	06120
31	Novartis Investigative Site	Hamburg		Germany	20095
32	Novartis Investigative Site	Heidelberg		Germany	69115
33	Novartis Investigative Site	Heidelberg		Germany	69120
34	Novartis Investigative Site	Hoppegarten		Germany	15366
35	Novartis Investigative Site	Hoyerswerda		Germany	02977
36	Novartis Investigative Site	Ingelheim		Germany	55218
37	Novartis Investigative Site	Jerichow		Germany	39319
38	Novartis Investigative Site	Kassel		Germany	34121
39	Novartis Investigative Site	Kiel		Germany	24106
40	Novartis Investigative Site	Kitzingen		Germany	97318
41	Novartis Investigative Site	Lahnau		Germany	35633
42	Novartis Investigative Site	Limbach-Oberfrohna		Germany	09212
43	Novartis Investigative Site	Ludwigshafen		Germany	67067
44	Novartis Investigative Site	Lutherstadt Wittenberg		Germany	06886
45	Novartis Investigative Site	Markkleeberg		Germany	04416
46	Novartis Investigative Site	Moers		Germany	47441
47	Novartis Investigative Site	Muellheim		Germany	79379
48	Novartis Investigative Site	Nuernberg		Germany	90461
49	Novartis Investigative Site	Oberhausen		Germany	46149
50	Novartis Investigative Site	Osnabrueck		Germany	49074
51	Novartis Investigative Site	Papenburg		Germany	26871
52	Novartis Investigative Site	Peine		Germany	31224
53	Novartis Investigative Site	Potsdam		Germany	14471
54	Novartis Investigative Site	Radebeul		Germany	01445
55	Novartis Investigative Site	Rastatt		Germany	76437
56	Novartis Investigative Site	Remscheid		Germany	42859
57	Novartis Investigative Site	Rostock		Germany	18107
58	Novartis Investigative Site	Rotenburg an der Fulda		Germany	36199
59	Novartis Investigative Site	Saarlouis		Germany	66740
60	Novartis Investigative Site	Schoenebeck		Germany	39218
61	Novartis Investigative Site	Schwandorf		Germany	92421
62	Novartis Investigative Site	Siegen		Germany	57072
63	Novartis Investigative Site	Speyer		Germany	67346
64	Novartis Investigative Site	Stadtbergen		Germany	86391
65	Novartis Investigative Site	Stahnsdorf		Germany	14532
66	Novartis Investigative Site	Ulm		Germany	89077
67	Novartis Investigative Site	Wedemark		Germany	30900
68	Novartis Investigative Site	Wenden		Germany	57482
69	Novartis Investigative Site	Winsen		Germany	21423
70	Novartis Investigative Site	Wismar		Germany	23966