High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure

NCT02823626 | Completed

• 1 other identifier: HSC20160252H
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Aims

1. 1.Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients.
2. 2.Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (2)

• Weight loss

  Improved swelling and shortness of breath suggestive of volume loss

  up to 10 days

• symptoms relief

  Improved swelling and shortness of breath suggestive of volume loss

  up to 10 days

Secondary Outcomes (2)

• Hypo- or hyperkalemia

  up to 10 days

• Urinary FENa and Urinary Na/K ratio

  Up to 10 days

Study Arms (1)

Intervention

Spironolactone and patiromer

Drug: Spironolactone and patiromer

Interventions

Spironolactone and patiromer DRUG

High dose spironolactone with or without patiromer based on the patient's baseline potassium

Also known as: Aldactone and veltassa

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will have been hospitalized with a diagnosis of chronic heart failure.

You may qualify if:

• More than18 years old
• Hospitalized with history of chronic heart failure and at least one symptom (dyspnea, orthopnea or edema) and one sign (rales, peripheral edema, ascites, or radiographic pulmonary edema or pleural effusion)
• Use of loop diuretics
• Women of child bearing age with negative urine pregnancy test

You may not qualify if:

• Acute coronary syndrome
• Patients with a baseline eGFR \< 30 ml/min by MDRD equation
• Baseline potassium concentration ≥ 5.5 mEq/L
• Requirement for intravenous vasodilators or inotropic agents
• Systemic infection
• Patients with concomitant end-stage liver disease
• Hemodynamically significant uncorrected valvular disease
• Patients with pulmonary embolism
• Patients with high output heart failure
• Pregnant patients

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Relypsa, Inc.: collaborator

Study Sites (1)

Shweta Bansal

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Spironolactone; patiromer

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shweta Bansal

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 6, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 3, 2019

Record last verified: 2018-04

Locations

US (1)