Non Invasive Assessment of Heart Failure

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04078425

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction.
Portray the health profile of heart failure patients admitted in internal medicine department either heart failure with reduced ejection fraction or heart failure with preserved ejection fraction.
To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy
Vitamin D and its relation to cardiovascular disease and heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Aldosterone Antagonists	Early Phase 1

Detailed Description

Heart failure (HF) is a growing epidemic related to significant morbidity and mortality.

The prevalence of the disease continuously increases due to the ageing population and success in treating cardiovascular diseases that often precede HF.

Lifetime risk of HF is still high with 20-45% and strongly age-dependent . Structural or functional alterations in the heart lead to reduced cardiac output and rising intracardiac pressures.

The resulting HF syndrome comprises typical symptoms such as dyspnoea, ankle swelling and fatigue .

Heart failure is classified into right sided heart failure and left sided heart failure,the later one is classified to HF with reduced EF (HFrEF) involving patients with an EF< 40% and heart failure with preserved ejection fraction (HFpEF) The proportion of HFpEF seems to be slightly lower than that of HFrEF .

For patients presenting with breathlessness, there is a need for a reliable biomarker for the early diagnosis of heart failure. Similarly, there is also a need for better monitoring of patients receiving treatment for heart failure. Non-invasive means such as a biomarker have therefore become useful.

There are many potential biomarkers for heart failure, the investigators will discuss the biomarkers that are available for clinical use in patients with heart failure to further assess prognosis and possibly direct HF therapy.

There is evidence that aldosterone antagonists can oppose the effect of aldosterone in promoting cardiac fibrosis.Furthermore, elevated levels of cardiac aldosterone have been demonstrated in a rat model of hypertensive diastolic HF, and use of the aldosterone antagonist, eplerenone, was associated with attenuation of left ventricular diastolic dysfunction and reduction in left ventricular mass and fibrosis in this model.Thus, aldosterone antagonism has the potential to be a beneficial therapeutic strategy in patients with HFpEF.

Vitamin D has the potential to improve the symptoms ofheart failure (HF) and to modulate the disease,Vitamin D supplementation can reduce blood pressure and improve skeletal muscle function and strength.

Animal studies suggest that active vitamin D down-regulates the renin-angiotensin-aldosterone system (RAAS), reduces retention of salt and water, and reduces myocardial hypertrophy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

Non Invasive Assessment of Heart Failure

Anticipated Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HF with preserved EF 50patients of heart failure with preserved ejection fration will receive anti.failure treatment(lanoxin,beta blocker,diuretics) for one month with follow up echocardiography before and after	Drug: Aldosterone Antagonists aldosterone antagonist will be applied to patients of heart failure with preserved ejection fraction, level of the drug will be sampled before administration of the drug and follow up will be sampled after one month
Experimental: HF with preserved EF recive eplernone 50 patients with heart failure with preserved ejection frationnwill receive traditional anti-failure treatment in addition to aldosterone antagonist (Eplernone) with follow up echocardiography and aldosterone level before and after	Drug: Aldosterone Antagonists aldosterone antagonist will be applied to patients of heart failure with preserved ejection fraction, level of the drug will be sampled before administration of the drug and follow up will be sampled after one month

Arm

Intervention/Treatment

Experimental: HF with preserved EF

50patients of heart failure with preserved ejection fration will receive anti.failure treatment(lanoxin,beta blocker,diuretics) for one month with follow up echocardiography before and after

Drug: Aldosterone Antagonists

aldosterone antagonist will be applied to patients of heart failure with preserved ejection fraction, level of the drug will be sampled before administration of the drug and follow up will be sampled after one month

Experimental: HF with preserved EF recive eplernone

50 patients with heart failure with preserved ejection frationnwill receive traditional anti-failure treatment in addition to aldosterone antagonist (Eplernone) with follow up echocardiography and aldosterone level before and after

Drug: Aldosterone Antagonists

Outcome Measures

Primary Outcome Measures

Role of aldosterone antagonist in treatment of heart failure [6months]
To evaluate the effect of aldosterone antagonist on exercise capacity of patients with established and symptomatic HFPEF and to evaluate the effect of aldosterone antagonist on diastolic function (the lateral mitral annular doppler tissue imaging measurments were used for assessment of early diastolic relaxation velocity (E'),ameasure of ventricular relaxation and for calculation of E\E'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

clinical diagnosed heart failure dyspnea grade III or IV
Heart failure with ejecton fraction ≤40

Exclusion Criteria:

Acute coronary syndrome.
Active infection
Chronic kidney diseased patients
Conn's disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

salma hamdy mahmoud haridi, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT04078425

Other Study ID Numbers:

Sharidi

First Posted:

Sep 6, 2019

Last Update Posted:

Jan 9, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by salma hamdy mahmoud haridi, Principal investigator, Assiut University

Heart failure

Echocardiography

Additional relevant MeSH terms:

Heart Failure

Mineralocorticoid Receptor Antagonists

Study Results

No Results Posted as of Jan 9, 2020