NCT06632353

Brief Summary

Sampling of dISF and blood plasma for qualitative measurements.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress92%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

October 7, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

October 7, 2024

Last Update Submit

January 23, 2026

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Presence of dISF biomarker

    Presence or not

    Day 1

Study Arms (2)

Group 1

Cardiovascular diseases

Group 2

Reference

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers and subjects recruited at hospital

You may qualify if:

  • Group 1: Chronic heart failure with stable therapy. NYHA classification II, III and IV. Age \> 60 years. Group 2: Age 18-40 years.

You may not qualify if:

  • Participating in another clinical investigation which may affect the study outcome according to clinical judgement.
  • Previous use of sampling system used.
  • Pregnancy or lactating.
  • Any disease or condition that may be affected.
  • Individuals who lack the ability to fully consent to participate in the study.
  • Severe skin injury.
  • Tattoo or piercing close to sampling area.
  • Group 1: All forms of emergency care.
  • Group 1: Non-stable therapy.
  • Group 1: Sepsis.
  • Group 1: BMI \> 30kg/m2.
  • Group 1: Age \> 84 years.
  • Group 2: Known heart or vascular disease.
  • Group 2: Diabetes.
  • Group 2: Kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Danderyd, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

dISF sample, plasma sample

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

October 8, 2024

Primary Completion

November 5, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

SE(1)