Trials
Search / Trial NCT06418932

Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure

Launched by FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE VALENCIA · May 16, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of compression therapy on the lower limbs in patients with a condition called decompensated heart failure, which means the heart is not pumping well and causing fluid buildup in the body. The trial aims to see if adding compression therapy to the standard treatment of a medication called furosemide (a diuretic that helps remove excess fluid) improves symptoms and safety for patients. Participants will be randomly assigned to either receive just furosemide or furosemide along with lower limb compression therapy for up to 72 hours.

To participate, individuals must be at least 18 years old and diagnosed with acute decompensated heart failure within the last four days. They should have been treated with furosemide and show signs of fluid retention, such as swelling in the legs. However, those with severe kidney issues, certain heart conditions, or previous problems with compression bandages cannot take part in the trial. If eligible, participants can expect close monitoring by healthcare professionals and guidance throughout the study. This trial is currently recruiting and welcomes all genders.

Gender

ALL

Eligibility 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.

About Fundación Para La Investigación Del Hospital Clínico De Valencia

The Fundación para la Investigación del Hospital Clínico de Valencia is a prominent research organization dedicated to advancing medical knowledge and improving patient care through clinical trials and biomedical research. Based in Valencia, Spain, the foundation collaborates closely with the Hospital Clínico Universitario de Valencia to facilitate innovative studies across various medical disciplines. Its mission is to promote scientific excellence and foster collaboration among healthcare professionals, researchers, and institutions, ultimately aiming to translate research findings into effective therapies and interventions for the benefit of patients and the broader community.

Locations

Barcelona, , Spain

Valencia, , Spain

Madrid, , Spain

Valencia, , Spain

Madrid, , Spain

Denia, Alicante, Spain

Murcia, , Spain

Torrevieja, Alicante, Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0