NCT02949544

Brief Summary

This study aims to investigate the effects of water immersion and exercise on heart function and blood flow in patients with chronic stable heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

November 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

October 13, 2016

Last Update Submit

June 17, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

    15 minutes of water immersion

Secondary Outcomes (10)

  • Heart rate (beats/minute)

    15 minutes of water immersion

  • Blood pressure (mmHg)

    15 minutes of water immersion

  • systemic vascular resistance (dyn·s/cm5)

    15 minutes of water immersion

  • Stroke volume (millilitres)

    15 minutes of water immersion

  • Jugular venous pressure (not raised, raised 1-4cm, raised to earlobes, undetectable)

    15 minutes of water immersion

  • +5 more secondary outcomes

Study Arms (1)

water immersion

OTHER

patients with heart failure will be immersed to the neck for 15 minutes

Other: water immersion

Interventions

water immersionOTHER

warm water immersion

water immersion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Established diagnosis of heart failure with NTpro BNP \>100

You may not qualify if:

  • Uncontrolled or severe heart failure, defined by NYHA class IV symptoms (breathlessness at rest)
  • Severe fluid overload characterised as more than minimal pitting oedema of the ankles only
  • Presence of haemodynamically significant valvular heart disease in the opinion of the investigator
  • Haemoglobin \<125 g/L
  • Weight \>120 kilograms
  • Requiring long term oxygen supplementation in the community
  • Hospitalisation for any cause within the last 6 weeks, that in the opinion of the investigator would affect the patients wellbeing in this study
  • Unstable or severe stable angina that requires three or more antianginals
  • Patients known to have disease causing immunocompromise such as HIV infection or undergoing chemotherapy
  • Patients with active infection
  • Dialysis patients
  • Uncontrolled seizures; patients in whom the pool environment may trigger seizures, new diagnosis of epilepsy
  • Insulin treated diabetic patients with hypoglycaemic episodes in the last 3 months.
  • Pregnant women
  • Central venous lines which are not tunnelled and are exposed superficially.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castle Hill Hospital

Cottingham, HU165JQ, United Kingdom

Location

Related Publications (1)

  • Shah P, Pellicori P, Kallvikbacka-Bennett A, Zhang J, Pan D, Clark AL. Warm water immersion in patients with chronic heart failure: a pilot study : Shah immerse: HF. Clin Res Cardiol. 2019 May;108(5):468-476. doi: 10.1007/s00392-018-1376-2. Epub 2018 Sep 28.

    PMID: 30267153RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andrew Clark

    Castle Hill Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 31, 2016

Study Start

November 22, 2016

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)