Compression therapy for heart failure patients
Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion
NA · Fundación para la Investigación del Hospital Clínico de Valencia · NCT06418932
This study tests if adding compression therapy to regular diuretics can help heart failure patients with fluid buildup feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia (other) |
| Locations | 8 sites (Denia, Alicante and 7 other locations) |
| Trial ID | NCT06418932 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the efficacy and safety of combining compression therapy of the lower limbs with parenteral diuretics compared to standard treatment with diuretics alone in patients experiencing decompensated heart failure. Participants will be randomly assigned to receive either standard treatment or the combination therapy for up to 72 hours. The study focuses on patients with systemic tissue congestion and aims to assess improvements in their condition through this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute decompensated heart failure and significant lower limb edema.
Not a fit: Patients in intensive care, those with severe renal failure, or significant peripheral artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance fluid management and improve outcomes for patients with decompensated heart failure.
How similar studies have performed: While the approach of combining compression therapy with diuretics is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older. * Patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment. * Patient treated with furosemide at least 40 mg in the last 24 hours. * NT-proBNP levels\>1000 pg/ml at least 1 time since the onset of decompensation. * Presence of tibio-malleolar edema at least grade II/IV at the time of inclusion. * Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit. Exclusion Criteria: * Being admitted to the Intensive Care Unit. * Renal transplant, chronic renal failure stage 5 (eGFR \<15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration. * Absence of peripheral pulses. * Ankle brachial index (ABI) \<0.9. * History of severe peripheral artery disease. * Previous intolerance to compressive bandaging. * HF secondary to acute myocardial infarction.
Where this trial is running
Denia, Alicante and 7 other locations
- Hospital de Denia — Denia, Alicante, Spain (RECRUITING)
- Hospital Universitario de Torrevieja — Torrevieja, Alicante, Spain (NOT_YET_RECRUITING)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (NOT_YET_RECRUITING)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (RECRUITING)
- Hospital Puerta de Hierro — Madrid, Spain (RECRUITING)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (RECRUITING)
- Hospital General de Valencia — Valencia, Spain (RECRUITING)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure