LUSA-HF: Liberal Use of Sodium in Ambulatory Heart Failure

• Sponsor: Ziekenhuis Oost-Limburg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04226755
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study investigates the effects of an increased sodium intake in heart failure patients with reduced ejection fraction and age-matched volunteers without heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Dietary Supplement: Sodium chloride	N/A

Detailed Description

At the start of the study, baseline investigations are performed including assessment of vital signs (blood pressure, heart rate, pulse oxygen saturation), weight, Everest congestion score (consisting of grading of dyspnea, orthopnea, jugular venous distention, rales, edema and fatigue), echocardiography, 24h urine collection, bio-impedance measurements and blood sample analysis with plasma renin and aldosterone Subsequently, a run-in phase of 2 weeks, without intervention, will start. After this run-in period, participants will be reassessed with the same baseline investigations. In addition, a skin biopsy will be performed as well as a blood volume measurement.

In the next phase of the study, salt intake will be increased with 3 grams daily. The salt will be packed in capsules containing 1 g of sodium chloride (NaCl). Patients will be asked to take one capsule with their breakfast, lunch and dinner. Every 2 weeks a follow-up visit is planned.

After 4 weeks of increased salt intake, a new skin biopsy will be taken and a blood volume measurement will be performed.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Liberal Use of Sodium in Ambulatory Heart Failure
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heart failure After a run-in phase of 2 weeks, patients will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks. A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks.	Dietary Supplement: Sodium chloride; 1 gram tid (with every meal)
Active Comparator: Healthy volunteer After a run-in phase of 2 weeks, volunteers will add 3 g of sodium chloride to every meal, using a NaCl tablet of 1 g. They will continue the sodium tablet for 4 weeks with a study visit every 2 weeks.A skin biopsy will be performed before the start of the augmented salt intake and after 4 weeks.	Dietary Supplement: Sodium chloride; 1 gram tid (with every meal)

Outcome Measures

Primary Outcome Measures

1. Changes in skin glycosaminoglycan (GAG) content [4 weeks]

2. Changes in skin sodium content [4 weeks]

Secondary Outcome Measures

1. Changes in blood volume assessed by radiolabeled red blood cell technique [4 weeks]

2. Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance) [6 weeks]

3. Changes in renal sodium handling [6 weeks]

4. Changes in cardiac geometry assessed by echo [6 weeks]

5. Changes in renal venous flow pattern [6 weeks]

Other Outcome Measures

1. Changes in Everest congestion score [6 weeks]

   The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion)

2. Changes in weight [6 weeks]

3. Changes in blood pressure [6 weeks]

4. Changes in thirst visual analogue scale (VAS) [6 weeks]

   The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst.

5. Changes in aldosterone [6 weeks]

6. Changes in renin [6 weeks]

7. Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP) [6 weeks]

   NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter

8. Occurrence of congestion [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Heart failure patients:

• Left ventricular ejection fraction ≤40% on echocardiogram obtained at inclusion

• Stable dose of guideline-recommended disease modifying drugs for at least 3 months.

• Maximum daily loop diuretic dose of 40 mg furosemide equivalents with a stable dose for the last month

1. Healthy volunteers:

• Age > 60 y

• Normal ejection fraction (>50%) without heart failure

• No neurohormonal blockers for hypertension

• Normal NT-proBNP

Exclusion Criteria:

• Heart failure hospitalization for congestion or myocardial infarction in past 3 months

• Permanent atrial fibrillation

• New York Heart Association (NYHA) class III-IV

• Estimated glomerular filtration rate (eGFR) < 30 mL/min

• Signs of congestion

• Severe right ventricular dysfunction

• Severe valvular disease

• Cardiothoracic anatomy not allowing satisfactory and reproducible recordings of echocardiogram

• Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Oost-Limburg	Genk		Belgium	3600

Sponsors and Collaborators

• Ziekenhuis Oost-Limburg

Investigators

• Principal Investigator: Jeroen Dauw, MD, Ziekenhuis Oost-Limburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wilfried Mullens, Principal investigator, Ziekenhuis Oost-Limburg
• ClinicalTrials.gov Identifier: NCT04226755
• Other Study ID Numbers: ZOLCAR19001
• First Posted: Jan 13, 2020
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wilfried Mullens, Principal investigator, Ziekenhuis Oost-Limburg: Sodium; Salt; Heart Failure
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jun 3, 2022