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The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia

NCT01748331 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-10-28

No results posted yet for this study

Summary

The purpose of this study is to determine the effect of fluid restriction and the neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger increase in plasma sodium than standard treatment in patients with decompensated heart failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change is greater in patients treated with strict fluid restriction versus standard treatment.

Conditions

Interventions

OTHER

Fluid restriction

Patients will be randomized to strict fluid restriction \< 1 L/day versus moderate fluid restriction \< 2.5 L/day

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Finn Gustafsson

    lead OTHER

Principal Investigators

  • Finn Gustafsson, MD, PhD, DMSci · Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748331 on ClinicalTrials.gov