Liberal Use of Sodium in Ambulatory Heart Failure

NCT ID: NCT04226755

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-06-30

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium chloride

Intervention Type: DIETARY_SUPPLEMENT

1 gram tid (with every meal)

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.

Group Type: ACTIVE_COMPARATOR

Sodium chloride

Intervention Type: DIETARY_SUPPLEMENT

1 gram tid (with every meal)

Interventions

Sodium chloride

1 gram tid (with every meal)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Wilfried Mullens

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeroen Dauw, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

Other Identifiers

ZOLCAR19001

Identifier Type: -

Identifier Source: org_study_id