Liberal Use of Sodium in Ambulatory Heart Failure

Heart Failure Clinical Trial

— LUSA-HF  

Official title:

Liberal Use of Sodium in Ambulatory Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226755
• Other study ID #: ZOLCAR19001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Sodium chloride
1 gram tid (with every meal)

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Everest congestion score	The Everest score assesses congestion, based on a point scale with a range from 0 (no congestion) to 18 (worst congestion)	6 weeks
Other	Changes in weight		6 weeks
Other	Changes in blood pressure		6 weeks
Other	Changes in thirst visual analogue scale (VAS)	The scale ranges from 0 -100 with 0 indicating no thirst and 100 the worst thirst.	6 weeks
Other	Changes in aldosterone		6 weeks
Other	Changes in renin		6 weeks
Other	Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP)	NT-proBNP will be measured using Roche diagnostics assay (Mannhein, Germany) and expresed as picogram per liter	6 weeks
Other	Occurrence of congestion		4 weeks
Primary	Changes in skin glycosaminoglycan (GAG) content		4 weeks
Primary	Changes in skin sodium content		4 weeks
Secondary	Changes in blood volume assessed by radiolabeled red blood cell technique		4 weeks
Secondary	Changes in extracellular, intravascular volume and total body fluid volume (assessed with bioimpedance)		6 weeks
Secondary	Changes in renal sodium handling		6 weeks
Secondary	Changes in cardiac geometry assessed by echo		6 weeks
Secondary	Changes in renal venous flow pattern		6 weeks